FDA approves Takeda’s Entyvio

Takeda’s new biologic therapy, Entyvio, has been approved in the US for ulcerative colitis and Crohn’s disease.

The drug is entering a hugely competitive marketplace, dominated by the TNF blocker drugs, led by AbbVie’s Humira.

Entyvio (vedolizumab) is an integrin receptor antagonist, the same class as Biogen Idec’s Tysabri. The new drug has been approved for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Takeda have positioned the drug as an option for patients who are intolerant or have lost response to a TNF blocker.

Entyvio is expected to have only a relatively modest impact on the existing immunology market, with analysts forecasting sales of around $500m by 2018. One of the downsides to the drug is that it is given via infusion, rather than the subcutaneous route of some TNF blockers

Takeda is developing a subcutaneous formulation of the drug, which is expected to reach the market by 2018.

The dose regimen for the drug is 300 mg infused intravenously over around 30 minutes at zero, two and six weeks, then every eight weeks thereafter.

In March, Entyvio received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), with final approval expected soon.

Safety

Entyvio is in the same class as Tysabri (Natalizumab) which has been shown to induce the potentially fatal rare neurological condition PML. The condition causes a JC virus infection, which has seen patients on Tysabri die from the condition, before regulators put in place a safety monitoring system.

For that reason risk of PML cannot be ruled out, and patients on Entyvio must be monitored for any new or worsening neurological signs or symptoms.

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